This is a randomized, double-blind, placebo-controlled, parallel, 24-week, Phase 2 safety/efficacy study in which three dose levels of EVP-6124 or placebo will be evaluated. Eligible for enrollment will be patients who meet clinical criteria for mild to moderate probable Alzheimer's disease who are either receiving treatment with AChEI medication at a stable dose or who are not presently taking any AChEI or memantine co-medication.

Patients will be randomized to one of the following groups: 0.3 mg, 1 mg or 2 mg or Placebo. Approximately 400 subjects will be randomized to the 4 treatment groups. Study drug will be supplied as capsules and will be orally administered once daily for a total of 24 weeks.

Eligibility

Ages Eligible for Study:

50 Years to 85 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Subjects with Probable Alzheimer's disease

Mini-Mental State Examination (MMSE) score of 14 to 24 inclusive at screening and a CDR-SB score ≥2 at the screening assessment

Modified Hachinski Ischemic Score (mHIS) ≤4 at screening

Female subjects are ≥1 year post-menopausal or are surgically sterile

Caregiver available; if not living in the same household, caregiver sees subject at least four times each week

Subject living at home, senior residential setting, or an institutional setting without the need for continuous nursing care

General health status acceptable for participation in a 24 week clinical trial be administered

Exclusion Criteria:

General

Participation in another therapeutic clinical trial within 30 days before Baseline

Prior participation in an amyloid vaccination clinical study

Inability to swallow capsules

Likely inability to complete 24 week study

Inability to be ≥75% compliant with single-blind placebo run-in medication

Inability to adequately perform cognitive tests

History of significant cardiovascular disease

Major depression

Psychosis

History of stroke within 18 months of screening

Head trauma

Inability to perform any screening or baseline evaluations

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01073228

United States: Food and Drug AdministrationRussia: Ministry of Health of the Russian FederationRomania: National Medicines AgencyUkraine: State Pharmacological Center - Ministry of HealthSerbia and Montenegro: Agency for Drugs and Medicinal Devices